Presentation to Health Secretary TRI PS Article 39.3 & Data Exclusivity (Regulatory Data Protection) by D G Shah Secretary General I ndian Pharmaceutical Alliance New Delhi New Delhi 6 May 2015 1
TRI PS Article 39.3 & Data Exclusivity Outline of Presentation Outline of Presentation TRIPS Article 39.3 & Its Genesis Impact of Data Exclusivity f l Summing Up g p 2 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis Protection of Undisclosed I nformation Article 39.3 Protection of Undisclosed I nformation Article 39 3 “Members Members, when requiring, as a condition of approving the when requiring as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed t he origination of which involves a test or other data, considerable effort, shall protect such data against unfair commercial use. commercial use In addition, Members shall protect such In addition Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data p , p are protected against unfair commercial use.” 3 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis US Submission to Negotiating Group in 1987 US Submission to Negotiating Group in 1987 Introduced Concept of Trade Secrets Sought Prevention of Misappropriation by Sought Prevention of Misappropriation by Unauthorised Use Provided Exception for Disclosure Provided Exception for Disclosure, if Disclosure did Not Impair Market Proposal for “Misappropriation Regime” and Not for Conferring Rights 4 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis Subsequently Changed by Trilateral Business Communities Subsequently Changed by Trilateral Business Communities Protection of Test Data Information Disclosed to Government Shall Not be Used Commercially Without the Consent of the Owner Information Disclosed as a Condition for Registration of o at o sc osed as a Co d t o o eg st at o o a Product shall be for the Exclusive Use of the Registrant for a Reasonable Period from the Date of Approval 5 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis Delegates Deferred with the Trilateral and Argued Delegates Deferred with the Trilateral and Argued Trade Secret did not Constitute IP IP Requirement q of Disclosure Can Not be Enforced on Trade Secret Fell Outside the Scope of the Negotiating Group Fell Outside the Scope of the Negotiating Group However, Recognized Need for Protection of Know–How Under Relevant Laws Know How, Under Relevant Laws 6 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis Text of Draft Submitted to Brussels Ministerial Conference in 1990 “Parties, when requiring as a condition of approving the marketing of pharmaceutical product or of a new agricultural chemical product, the submission of undisclosed tests or other data, the origination of which involves a considerable effort shall protect such data against unfair commercial use. Unless the Person submitting this information agrees, the data may not be relied upon for the approval of competing products for a reasonable time, generally no less than five years, commensurate with the generally no less than five years, commensurate with the efforts involved in the origination of the data, their nature and the expenditure involved in their preparation. In addition parties shall protect such data against disclosure protect such data against disclosure, except where necessary to except where necessary to protect the public” (emphasis added). The Final Text of the TRI PS Agreement Did Not Mention The Final Text of the TRI PS Agreement Did Not Mention Period of Non-reliance 7 I PA: 05/ 15
TRI PS Article 39.3 & I ts Genesis Protection of Undisclosed Test Data Protection of Undisclosed Test Data Member States’ obligation is to protect “undisclosed Member States obligation is to protect undisclosed test or other data” submitted to Regulatory Authority against “unfair commercial use” Authority against unfair commercial use It does not mean “Market Exclusivity”; and It does not mean Market Exclusivity ; and Use of originator’s data for regulatory approval is “not unfair commercial use ” not unfair commercial use. 8 I PA: 05/ 15
I mpact of Data Exclusivity on Access Brand I ndustry Seeks Two Layers of Protection Brand I ndustry Seeks Two Layers of Protection Non disclosure: Authorities will keep the data secret Non-disclosure: Authorities will keep the data secret and will not disclose it to third parties N Non-use: H Health lth Authorities A th iti will ill not t compare th the submissions of a generic applicant (bio-equivalence tests) to the parallel results of the innovator for the tests) to the parallel results of the innovator for the purpose of approving the generic product Non-use Exceeds Obligations Under TRI PS Article 39.3 Patent Protection Period was Raised to 20-Year Patent Protection Period was Raised to 20 Year to Cover Costs of Creating Data for Product Registration 9 I PA: 05/ 15
I mpact of Data Exclusivity on Access I mplications of Exceeding TRI PS Obligations I mplications of Exceeding TRI PS Obligations Longer than 20-Year Market Monopoly L th 20 Y M k t M l Delay in Entry of Generics Protection to Weak Patents Tool for “Evergreening”/Dilution of Sec 3(d) Tool for Evergreening /Dilution of Sec 3(d) Incentive to Delay Launch of New Products Offers Market Exclusivity to Pre-1995 Molecules Monopoly Beyond Patents 10 I PA: 05/ 15
I mpact of Data Exclusivity on Access I mplications of 10-Year “Data Exclusivity” YEARS 0 20 23 13 CLINICAL DEVELOPMENT & & MARKET MARKET REGULATORY EXCLUSIVITY APPROVAL PATENT GENERIC PATENT REGULATORY FILING APPROVAL EXPIRY APPROVAL 0 20 23 13 11 I PA: 05/ 15
I mpact of Data Exclusivity PhRMA “Special 301” Submissions I ndia: Damage Estimate - 2003 CRA Study “conservatively estimates losses in India due to the absence CRA Study conservatively estimates losses in India due to the absence of intellectual property protection at more than $1.7 billion dollars annually.” I ndia: Damage Estimate - 2005 Damage estimate of $1 7bn in 2001 was revised to $ 3 5 bn in 2005 ! Damage estimate of $1.7bn in 2001 was revised to $ 3.5 bn in 2005 ! Patent Protection Damages $ 2.5 Bn Data Protection Damages D P i D $ 1 0 B $ 1.0 Bn Total Damage Estimate kk;lk;lk $ 3.5 Bn This Constitutes 78% of the I ndian Market 12 I PA: 05/ 15
Summing Up Recommendation by the WHO Commission Recommendation by the WHO Commission* "A public health justification should be required for data A public health justification should be required for data protection rules going beyond what is required by the TRIPS Agreement. g There is unlikely to be such a justification in markets with a limited ability to pay and little innovative capacity. Thus, developing countries should not impose restrictions for the use of or reliance h ld t i t i ti f th f li on such data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS " or impede the use of flexibilities built into TRIPS. * The WHO Commission on Intellectual Property Rights, Innovation and Public Health, Pg 126 13 I PA: 05/ 15
Summing Up Recommendation of the Parliamentary Standing Committee on Commerce Recommendation of the Parliamentary Standing Committee on Commerce* “Since the consequences of Data Exclusivity are quite serious, the Committee strongly recommend that the Government should not fall prey to such demands of MNCs. The Government must thwart such attempts, being MNCs The Government must thwart such attempts being made at the behest of certain vested interests. It should also guard against moves to enter into FTA with USA, as also guard against moves to enter into FTA with USA, as the developed countries, particularly the USA, are trying to bring in certain TRIPS Plus measures through Bilateral and Regional Agreements.” * Eighty Eighth Report on Patents and Trademarks Systems in India, Eighty Eighth Report on Patents and Trademarks Systems in India, New Delhi, October 2008, Rajya Sabha Secretariat 14 I PA: 05/ 15
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